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NCT01745588 · OUTCOME

Overall Response Rate

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma · Source last updated 2026-09-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
at 9 months after the start of treatment

What was measured

Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Groups in this outcome

Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell

All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Pomalidomide stem cell Clarithromycin

Clarithromycin + Pomalidomide + Dexamethasone Alone

All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Pomalidomide Dexamethasone Clarithromycin

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell12
Clarithromycin + Pomalidomide + Dexamethasone Alone11

Reported measurements

Source class 1

Overall Response Rate (Partial Response or Better)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell8Not reportedNot reportedNot reportedNot reported
Clarithromycin + Pomalidomide + Dexamethasone Alone5Not reportedNot reportedNot reportedNot reported

Stable Disease or Progression

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell4Not reportedNot reportedNot reportedNot reported
Clarithromycin + Pomalidomide + Dexamethasone Alone6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      title
      Overall Response Rate (Partial Response or Better)
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      title
      Stable Disease or Progression
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Very Good PR or greater will be evaluated nine months postrandomization according to International Uniform Response Criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion. Pomalidomide stem cell Clarithromycin
    id
    OG000
    title
    Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell
  2. description
    All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD. Pomalidomide Dexamethasone Clarithromycin
    id
    OG001
    title
    Clarithromycin + Pomalidomide + Dexamethasone Alone
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
at 9 months after the start of treatment
title
Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice